CymaBay price target raised to $13 from $9 at H.C. Wainwright » 06:1808/0408/04/20
H.C. Wainwright analyst…
H.C. Wainwright analyst Ed Arce raised the firm's price target on CymaBay Therapeutics to $13 from $9 and keeps a Buy rating on the shares. The company yesterday announced "strongly positive" results from the Phase 3 ENHANCE study of seladelpar in primary biliary cholangitis, Arce tells investors in a research note. The analyst says the results "confirm and strengthen" his conviction that seladelpar is likely a best-in-class treatment for PBC.
CymaBay price target raised to $20 from $15 at Cantor Fitzgerald » 13:0708/0308/03/20
Cantor Fitzgerald analyst…
Cantor Fitzgerald analyst Eliana Merle raised the firm's price target on CymaBay to $20 from $15 and reiterates an Overweight rating on the shares. The stock in afternoon trading is up 43%, or $1.52, to $5.06. This morning's primary biliary cholangitis data and the restart of clinical studies increases conviction in the shares, Merle tells investors in a research note. The data show "best-in-class efficacy and safety," says the analyst. Merle thinks these data, coupled with the recent FDA lifting of clinical hold and near-term restart of clinical studies "bode very well" for CymaBay's success in primary biliary cholangitis. The analyst says the company's "comeback story is just beginning."
Street missing 'eye-catching' CymaBay data, says Piper Sandler » 12:5308/0308/03/20
This morning's topline data from CymaBay's halted Phase 3 ENHANCE study answered key questions for seladelpar around its effect on itch, a hallmark symptom of primary biliary cholangitis, Piper Sandler analyst Yasmeen Rahimi tells investors in a research note. From this 167-patient, placebo-controlled dataset analyzed at three months, CymaBay showed "eye-catching" pruritus improvements for 10mg daily seladelpar in patients with moderate-to-severe itch, says Rahimi. The analyst adds that with CymaBay still trading near cash, the Street is "missing the importance of today's news." With itch causing fatigue and other quality-of-life issues in patients, improved pruritus can command a "significantly higher pricing dynamic" than current options that only address disease biomarkers, contends Rahimi. The analyst sees today's readout as "significantly moving the needle" on seladelpar's commercial potential in PBC. Rahimi keeps an Overweight rating on CymaBay with a $12 price target. The stock in midday trading is up 46%, or $1.65, to $5.20.
CymaBay price target raised to $13 from $8 at Stifel » 12:1408/0308/03/20
Stifel analyst Derek…
Stifel analyst Derek Archila raised the firm's price target on CymaBay to $13 from $8 and keeps a Buy rating on the shares after the company reported positive results from seladelpar's Phase 3 study in PBC patients. Archila tells investors in a research note that while the results are from a study that was not fully completed due to the clinical hold which has now been lifted and is only for a proportion of the patients from the study, he believes this data confirms seladelpar's robust and rapid efficacy in PBC and believes a full 52-week study is largely de-risked.
CymaBay announces topline results from ENHANCE for seladelpar » 07:1208/0308/03/20
CymaBay Therapeutics announced positive topline results from ENHANCE, a placebo-controlled, randomized, Phase 3 study evaluating the safety and efficacy of seladelpar for the treatment of primary biliary cholangitis. Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta agonist that has demonstrated anti-cholestatic and anti-inflammatory effects in clinical studies for PBC. ENHANCE was a double-blind, placebo-controlled, global study that randomized 265 PBC patients to placebo, seladelpar 5 mg, or seladelpar 10 mg once daily. Eligible patients had an inadequate response to UDCA or an interolerance to UDCA. The primary outcome measure was the responder rate defined as a patient who achieved an ALP level less than 1.67 x the ULN with at least a 15% decrease from baseline and a normal level of total bilirubin after 52 weeks. Due to the early termination of the study and the small number of patients who had reached the 52 week timepoint, the primary outcome measure was amended prior to database lock to a 3 month timepoint which was reached by 167 of 265 patients. Additional key analyses compared the rate of normalization of ALP and the burden of pruritus assessed by a numerical rating scale; these were also adjusted to a 3 month timepoint. At baseline, mean ALP levels were 293, 290, and 291 IU/L in the placebo, 5 mg, and 10 mg groups, respectively. Approximately 30% of patients enrolled had moderate-to-severe pruritus based on a NRS score greater than or equal to4 for itch at baseline. The baseline characteristics were balanced between the 3 groups and representative of a high-risk PBC patient population. Seladelpar achieved the primary composite outcome with high statistical significance in 78.2% of patients in the 10 mg group and 57.1% in the 5 mg group compared to 12.5% on placebo after 3 months. Rapid, dose-dependent reductions in ALP were observed as early as one month in seladelpar treated patients with mean decreases of 38%, 30%, and 2% in the 10 mg, 5 mg and placebo groups, respectively. The anti-cholestatic effect of seladelpar was further substantiated with normalization of ALP levels at 3 months in 27.3% of patients in the 10 mg group vs 0% in the placebo group. A similar pattern was achieved in these endpoints at 6 months but with smaller numbers of patients reaching this point in the study. Seladelpar also demonstrated a strong, dose-dependent reduction in pruritus after just 3 months of treatment in those patients with an NRS greater than or equal to4 when compared to placebo. A mean reduction of 3.2 points in pruritus NRS from baseline was observed in the 10 mg group compared to a mean 1.6 point reduction in the placebo group. Treatment with seladelpar also demonstrated robust anti-inflammatory activity at 3 months with mean ALT decreases of 17% in the 10 mg group vs 3% in the placebo group. The effect of seladelpar treatment on gamma-glutamyl transferase was also highly significant with a decrease of 36% in the 10 mg group compared to 7% in the placebo group. Total bilirubin remained stable across all 3 groups. Seladelpar demonstrated a favorable safety and tolerability profile. The adverse events were similar across the seladelpar and placebo groups. There were no grade 3 or higher ALT elevations observed.
CymaBay initiated with an Overweight at Piper Sandler » 16:2107/3007/30/20
Piper Sandler analyst…
Piper Sandler analyst Yasmeen Rahimi initiated coverage of CymaBay Therapeutics with an Overweight rating and $12 price target. With the clinical hold removed by the FDA on July 23, CymaBay the analyst has "strong conviction" that the topline data from the 100-patient, placebo-controlled, Phase 3 ENHANCE study to further increase confidence about seladelpar's potential in primary biliary cholangitis, Rahimi tells investors in a research note. The analyst sees 327% potential upside in the shares.
|Over a week ago|
CymaBay price target raised to $10 from $6 at Oppenheimer » 13:2407/2307/23/20
Oppenheimer analyst Jay…
Oppenheimer analyst Jay Olson raised the firm's price target on CymaBay to $10 from $6 and keeps an Outperform rating on the shares after the company announced that the FDA has lifted the clinical hold on seladelpar.
CymaBay clinical hold lift 'major clearing event,' says Stifel » 10:1207/2307/23/20
Stifel analyst Derek…
Stifel analyst Derek Archila reiterates a Buy rating on CymaBay Therapeutics with an $8 price target after the company announced that the FDA has lifted the clinical hold on seladelpar and it is re-initiating clinical development. This is a "major clearing event" and a positive, Archila tells investors in a research note. The analyst says CymaBay can benefit from orphan pricing, shorter development timelines in primary biliary cholangitis relative to than in nonalcoholic steatohepatitis, and the fact seladelpar has already generated positive Phase 2 proof-of-concept results. CymaBay shares in morning trading are up 32% to $4.63.
CymaBay upgraded to Strong Buy from Outperform at Raymond James » 09:3907/2307/23/20
Raymond James analyst…
Raymond James analyst Steven Seedhouse upgraded CymaBay to Strong Buy from Outperform with a $10 price target.
CymaBay announces FDA lifts all clinical holds on seladelpar » 08:0207/2307/23/20
CymaBay Therapeutics announced that the Food and Drug Administration lifted clinical holds on seladelpar for all three Investigational New Drug Applications in Nonalcoholic Steatohepatitis, Primary Biliary Cholangitis and Primary Sclerosing Cholangitis. On November 25, 2019, CymaBay halted all clinical trials of seladelpar after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end-of treatment biopsy review of a 52-week Phase 2 NASH study. The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold. CymaBay committed to an in-depth investigation of these findings and comprehensive safety evaluation that concluded with an independent, expert panel review involving some of the world's leading liver pathologists and hepatologists. The expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study and unanimously supported re-initiating clinical development of seladelpar pending approval by the FDA. Based on the results of the investigation and the expert panel conclusions, FDA concluded that clinical trials for NASH, PBC and PSC may resume.